Child: As nebuliser susp: 2 mg as a single dose, or in 2 divided doses of 1 mg given in a 30-minute interval. Doses may be repeated 12 hourly for up to 36 hours or until clinical improvement is observed.
Inhalation/Respiratory Asthma
Adult: As dry powder inhaler: 200-800 mcg daily; in more severe cases, doses up to Max of 1,600 mcg daily may be given. Doses ≤400 mcg daily may be administered once daily; >400 mcg daily doses may be given in 2-4 (usually 2) divided doses. As nebuliser susp: For severe asthma, or while reducing or stopping oral corticosteroids: Initially, 1-2 mg bid. Maintenance: 0.5-1 mg bid. Doses must be individualised based on asthma severity; use the lowest effective maintenance dose to achieve adequate symptom control. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: As dry powder inhaler: 5-12 years 200-800 mcg daily in 2 divided doses. Doses ≤400 mcg daily may be given once daily. >12 years Same as adult dose. As nebuliser susp: For severe asthma, or while reducing or stopping oral corticosteroids: 3 months to <12 years Initially, 0.5-1 mg bid. Maintenance: 0.25-0.5 mg bid. ≥12 years Same as adult dose. Doses must be individualised based on asthma severity; use the lowest effective maintenance dose to achieve adequate symptom control. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Nasal Allergic rhinitis
Adult: As 64 mcg/dose nasal spray: Initially, 2 sprays into each nostril once daily in the morning or 1 spray into each nostril bid (total daily dose: 256 mcg). Once symptom control is achieved, dose may be decreased to 1 spray into each nostril once daily. As 32 mcg/dose nasal spray: 2 sprays into each nostril once daily (total daily dose: 128 mcg), may reduce to 1 spray into each nostril once daily if symptoms improve. As 50 mcg/dose nasal spray: 2 sprays into each nostril bid (total daily dose: 400 mcg), may reduce to 1 spray into each nostril bid after 2-3 days. As 100 mcg/dose nasal spray: 2 sprays into each nostril once daily in the morning (total daily dose: 400 mcg), may reduce to 1 spray in each nostril in the morning after 2-3 days. Doses must be titrated to the lowest effective dose to maintain adequate symptom control. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: As 64 mcg/dose nasal spray: ≥6 years Same as adult dose. As 32 mcg/dose nasal spray: 6-<12 years 1 spray into each nostril once daily, may be increased to 2 sprays into each nostril once daily if needed. Once symptoms have improved, dose may be reduced to 1 spray into each nostril once daily. ≥12 years Same as adult dose. Titrate doses to the lowest effective dose to maintain adequate symptom control. Dosage recommendations and age range of use may vary among individual products and between countries (refer to specific product guidelines).
Nasal Nasal polyps
Adult: As 64 mcg/dose nasal spray: Initially, 1 spray into each nostril bid or 2 sprays into each nostril once daily in the morning (total daily dose: 256 mcg). As 100 mcg/dose nasal spray: 1-2 sprays into each nostril once daily in the morning (total daily dose: 200-400 mcg), then reduce to 1 spray in each nostril in the morning. Doses must be titrated to the lowest effective dose to maintain adequate symptom control. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Crohn's disease
Adult: As 3 mg modified-release or gastro-resistant cap: For mild to moderately active cases affecting the ileum and/or ascending colon: Induction of remission: 9 mg daily as a single dose before breakfast or in 3 divided doses about 30 minutes before meals for up to 8 weeks. Reduce the dose gradually 2-4 weeks before stopping therapy. For recurring episodes of active cases, an 8-week treatment course may be repeated. Maintenance of remission: 6 mg once daily for up to 3 months, then gradually reduce the dose before stopping the treatment. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Autoimmune hepatitis
Adult: As 3 mg gastro-resistant cap: In combination with azathioprine (only if patients are azathioprine tolerant): For induction of remission: 3 mg tid until remission is achieved. Maintenance of remission: 3 mg bid. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Ulcerative colitis
Adult: For induction of remission in patients with mild to moderately active cases, where 5-aminosalicylic acid (5-ASA) is insufficient: As 9 mg prolonged-release tab: 9 mg once daily in the morning without regard to meals for up to 8 weeks. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Microscopic colitis
Adult: As 3 mg modified-release or gastro-resistant cap: For induction of remission: 9 mg once daily in the morning for up to 8 weeks. Reduce the dose gradually in the last 2 weeks before stopping therapy. Maintenance of remission: 6 mg once daily in the morning or use the lowest effective dose. Alternatively, 6 mg once daily and 3 mg once daily to be taken on alternate mornings. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Primary immunoglobulin A nephropathy
Adult: As 4 mg modified-release cap: 16 mg once daily in the morning (approx 1 hour before meals) for 9 months. When stopping the treatment, reduce the dose to 8 mg once daily for 2 weeks; doses may be further reduced to 4 mg once daily for another 2 weeks if needed. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Eosinophilic oesophagitis
Adult: As orodispersible tab: For induction of remission: 1 mg bid to be taken after meals for 6 weeks, may be extended for up to 12 weeks in unresponsive patients. Maintenance of remission: 0.5-1 mg bid. The 1 mg bid maintenance dose may be given for patients with long-term disease or extensive oesophageal inflammation in the acute phase. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Rectal Ulcerative colitis
Adult: For cases involving the rectum and sigmoid colon: As retention enema: 2 mg in 100 mL once daily at bedtime for 4 weeks, may be extended to 8 weeks if the patient is not in remission after the initial 4-week treatment. As rectal foam: 2 mg (1 actuation) once daily for 6-8 weeks. Alternatively, 2 mg (1 actuation) bid for 2 weeks, then 2 mg (1 actuation) once daily at bedtime for 4 weeks. For mild to moderate cases limited to the rectum: As supp: 4 mg (1 supp) once daily at bedtime.
What are the brands available for Budesonide in Malaysia?
Primary immunoglobulin A nephropathy:
Severe: Contraindicated.
Administration
Budesonide May be taken with or without food. Recommendations on taking w/ or w/o food, opening cap, & crushing/chewing are product-specific. Avoid grapefruit juice. Consult product literature for specific instructions.
Contraindications
Oral inhalation: Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Oral: Severe hepatic impairment (when used for primary IgA nephropathy). Contraindications may vary among products and between countries (refer to specific product guidelines).
Special Precautions
Patient with CV disease (e.g. CHF, hypertension, recent MI), diabetes mellitus, family history of diabetes, hyperthyroidism, hypothyroidism; COPD; gastrointestinal disease (e.g. diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection), erosive oesophagitis; cataract, current or history of glaucoma; myasthenia gravis, osteoporosis, systemic sclerosis; pre-existing or history of affective disorders (e.g. manic-depressive disorder, previous steroid psychosis), history of seizure disorders; active or quiescent TB, ocular herpes simplex, untreated fungal, bacterial, systemic viral or parasitic infections; major risk factors for decreased bone mineral count (e.g. prolonged immobilisation, osteoporosis, postmenopausal status, tobacco use, poor nutrition). Carefully monitor patients switching from systemic corticosteroid therapy to oral inhalation, nasal or rectal corticosteroid therapy due to potential exacerbation of symptoms. Avoid exposure to chickenpox or measles. Avoid nasal administration in patients with epistaxis, recent nasal septal ulcers and nasal surgery or trauma until healing has occurred. Not indicated for the relief of acute bronchospasm or asthma attacks (oral inhalation). Avoid abrupt withdrawal. Children and elderly. Renal and hepatic impairment; avoid use in hepatic cirrhosis. Pregnancy and lactation.
Adverse Reactions
Significant: HPA axis suppression or hypercortisolism (particularly in children or at high doses for prolonged use); growth retardation in children; immunosuppression (prolonged use), delayed wound healing, increased risk of infection; Kaposi's sarcoma (prolonged use); fluid retention, electrolyte disturbances, hypertension, hyperglycaemia; new-onset or exacerbation of erosive oesophagitis; acute myopathy, transient worsening of myasthenia gravis, reduced bone mineral density, osteoporotic fractures; psychiatric disturbances (e.g. depression, anxiety, insomnia, euphoria); ocular effects (e.g. blurred vision, increased IOP, glaucoma, cataract, central serous chorioretinopathy); oesophageal, oral or oropharyngeal candidiasis; nasal septal perforation, nasal ulceration, epistaxis, and localised Candida albicans infection of the nose or pharynx (nasal); pneumonia (particularly in patients with COPD receiving inhaled doses); hypersensitivity reactions (e.g anaphylaxis, angioedema, urticaria, rash). Rarely, vasculitis or eosinophilic granulomatosis with polyangiitis (oral inhalation). Cardiac disorders: Palpitations. Gastrointestinal disorders: Nausea, diarrhoea, flatulence, GERD, dyspepsia, abdominal pain, dysgeusia, dry mouth; rectal pain or burning sensation (rectal enema). General disorders and administration site conditions: Peripheral oedema, fatigue. Investigations: Increased weight; decreased plasma cortisol. Metabolism and nutrition disorders: Cushingoid features, hypokalaemia. Musculoskeletal and connective tissue disorders: Muscle spasms, muscle or joint pain. Nervous system disorders: Headache. Psychiatric disorders: Irritability, euphoria, mood swings. Reproductive system and breast disorders: Menstrual disorders. Respiratory, thoracic and mediastinal disorders: Hoarseness, cough, nasal mucosa or throat irritation, oropharyngeal pain, nasal dryness or stinging sensation, sneezing. Skin and subcutaneous tissue disorders: Pruritus, acne, exanthema, petechiae, contact dermatitis. Potentially Fatal: Adrenal insufficiency (particularly for patients switched from systemic corticosteroid therapy); paradoxical bronchospasm (oral inhalation).
Nebuliser susp for oral inhalation: Not suitable for use in ultrasonic nebulisers.
Monitoring Parameters
Monitor LFTs at baseline; blood pressure, weight and growth (particularly in children), bone mineral density, serum glucose, electrolyte levels, and IOP (for >6 weeks therapy); FEV1, peak flow and other pulmonary function tests (oral inhalation). Screen for hepatitis B infection before treatment initiation. Assess for the signs and symptoms of infection, HPA axis suppression, glaucoma, cataracts, asthma, eosinophilic conditions, and oropharyngeal or nasal candidiasis. When used for primary IgA nephropathy: Obtain serum creatinine, eGFR, urine protein excretion and urinalysis at baseline and periodically during treatment.
Overdosage
Symptoms: Systemic corticosteroid effects (e.g. Cushingoid symptoms), especially for chronic cases. Management: Symptomatic and supportive treatment. Gradually reduce dose until treatment is discontinued.
Drug Interactions
May decrease the immune response with live vaccines. Increased plasma concentration and risk of systemic adverse effects with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, cobicistat-containing preparations, ritonavir, saquinavir, nefazodone, ciclosporin). May decrease the systemic exposure with CYP3A4 inducers (e.g. carbamazepine, rifampicin). May potentiate the effects of cardiac glycosides. May reduce bioavailability with antacids.
Food Interaction
Increased plasma concentration with grapefruit or grapefruit juice.
Lab Interference
May result in falsely low values on ACTH stimulation test for diagnosing pituitary insufficiency.
Action
Description: Mechanism of Action: Budesonide, a corticosteroid with potent glucocorticoid and weak mineralocorticoid activity, exerts high local anti-inflammatory effect and has limited systemic effects. Oral formulations used for the therapy of inflammatory bowel disease act by targeting the gastrointestinal tract. It controls the rate of protein synthesis, blocks the migration of polymorphonuclear leucocytes and fibroblasts, and reverses the capillary permeability and lysosomal stabilisation at the cellular level to control inflammation. Its action in primary IgA nephropathy is not fully elucidated, but it presumably targets mucosal B-cells in the ileum and/or systemically to inhibit the production of galactose-deficient IgA1 antibodies that cause IgA nephropathy. Onset: 24 hours (oral inhalation); 2-8 days (nebulisation). Pharmacokinetics: Absorption: Rapidly and almost completely absorbed (oral). Bioavailability: 9-21% (oral); 39% (oral inhalation). Time to peak plasma concentration: 0.5-2 hours (orodispersible tab); 13-14 hours (prolonged-release tab); 0.5-10 hours (modified-release cap); approx 5 hours (gastro-resistant cap); 10-30 minutes (oral inhalation); 30 minutes (nasal); 1.5 hours (rectal enema). Distribution: Widely distributed in tissues. Enters breast milk. Volume of distribution: Approx 2-4 L/kg. Plasma protein binding: 85-90%. Metabolism: Metabolised in the liver via oxidative pathways mainly by CYP3A4 into 16-α-hydroxyprednisolone and 6-β-hydroxybudesonide. Undergoes extensive first-pass metabolism (oral). Excretion: Via urine (approx 60%) and faeces as metabolites. Elimination half-life: 5-6.8 hours (4 mg modified-release cap); 2.13 hours (after 1 mg dose of orodispersible tab); 2-8 hours (3 mg modified-release or gastro-resistant cap); 2-3 hours (oral inhalation, nasal, rectal).
Chemical Structure
Budesonide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5281004, Budesonide. https://pubchem.ncbi.nlm.nih.gov/compound/Budesonide. Accessed Aug. 27, 2025.
Storage
Orodispersible tab/Modified-release tab or cap/Gastro-resistant cap: Store between 15-30°C. Protect from light and moisture. Inhaler/Nebuliser susp/Nasal spray/Rectal foam/Enema/Supp: Store between 20-25°C. Do not refrigerate or freeze. Protect from light, heat or direct sunlight. Storage recommendations may vary among individual products and between countries. Refer to specific guidelines.
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation. R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis. D07AC09 - budesonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
References
AFT Pharmaceuticals Ltd. Stereoclear 50 mcg and 100 mcg per actuation Aqueous Nasal Suspension data sheet 29 May 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 22/07/2025.AstraZeneca Limited. Pulmicort Turbuhaler 100 mcg, 200 mcg, and 400 mcg data sheet 3 August 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 22/07/2025.Brayfield A, Cadart C (eds). Budesonide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/07/2025.Budenofalk 2 mg/dose Rectal Foam (Dr. Falk Pharma GmbH). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Budenofalk 3 mg Gastro-resistant Capsules (Dr. Falk Pharma GmbH). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Budesonide (EENT). UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 22/07/2025.Budesonide (Nasal). 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Accessed 22/07/2025.Cortiment Prolonged Release Tablets 9 mg (Ferring Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/07/2025.Dr. Falk Pharma New Zealand Ltd. Jorveza Orally Disintegrating Tablet data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 22/07/2025.Entocort CR 3 mg Capsules (Tillotts Pharma UK Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Entocort Enema (Tillots Pharma UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Joint Formulary Committee. Budesonide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/07/2025.Jorveza 1 mg Orodispersible Tablet (Dr. Falk Pharma UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Kinpegyo 4 mg Modified-release Hard Capsules (Genus Pharmaceuticals Holdings Ltd., trading as STADA). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Nefecon Modified-release Capsules 4 mg (Everest Medicines II [HK] Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 22/07/2025.Pulmicort Flexhaler Aerosol Powder (H2-Pharma LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/07/2025.Pulmicort Respules (AstraZeneca Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/07/2025.Pulmicort Turbohaler 200 (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2025.Pulmicort Turbuhaler 100 and 200 micrograms/dose (AstraZeneca Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/07/2025.Rhinocort Aqua 64 mcg/dose (JNTL [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. 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